A Study With NLY01 in Subjects With Type 2 Diabetes

This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NLY01, a PEGylated Exenatide, When Administered as a Single Dose in Subjects With Type 2 Diabetes
Actual Study Start Date: October 16, 2019
Estimated Primary Completion Date: March 2020
Estimated Study Completion Date: March 2020

Arms:
- Active Comparator: NLY01 (2.5 mg)
- Active Comparator: NLY01 (5.0 mg)
- Active Comparator: NLY01 (10 mg)
- Placebo Comparator: Placebo